- Domestic Feline Companion Animals May
Serve as Reservoir for SARS-CoV-2 Infections in Humans -
Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the
"Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA
manufacturing that enables in vitro diagnostics, preclinical
nucleic acid-based therapeutic drug candidates, supply chain
security, anti-counterfeiting and anti-theft technology, today
announced that it and Evvivax, S.R.L., a spin-out of Takis Biotech
focused on engineered veterinary immunotherapy and vaccines, are
expected to initiate a veterinary clinical trial of one of the
Company’s five LineaDNA™ vaccine candidates upon approval of the
clinical plan by the U.S. Department of Agriculture. The goal of
the vaccine trial is to evaluate the vaccine candidate as a
strategy for the prevention of SARS-CoV-2 (COVID-19) (a zoonotic
disease) infections in companion felines of humans. The clinical
trial will seek to understand the immune response in cats by
utilizing a vaccination strategy of interest in people that could
yield valuable data for both cats and humans.
In addition to curbing feline SARS-CoV-2 infections, the vaccine
may have a secondary benefit of preventing transfer of the
SARS-CoV-2 virus from cats to their human owners. While no such
transfer has been formally documented to date, there is still much
that is unknown about the disease and its transmission across
species. The vaccine trial also serves the additional purpose of
generating data on larger animals required as part of the Company’s
preclinical development work on its vaccine candidates for
potential human development.
Veterinary COVID-19 Trial Design
The clinical trial is a New York State-based, single-center
trial that intends to enroll 30 healthy domestic feline companion
animals and follow them for six months. The study will evaluate
domestic feline immune response, safety, and tolerability of the
LineaDNA vaccine candidate, which will be injection once per month
at 1mg/month for the first three months of the trial. Dosing will
be administered intramuscularly via gene electrotransfer utilizing
electroporation technology. The primary endpoint is to determine
evidence of antibody and T-cell response in the companion
felines.
The trial will take place at Guardian Veterinary Specialists in
Brewster, N.Y., under the supervision of Dr. Joseph Impellizeri,
DVM, DACVIM (O), MRCVS from Veterinary Oncology Services, LLC
(link). Applied DNA and Evvivax will co-sponsor the trial. Applied
DNA's participation is approximately $100,000, and the Company will
supply a quantity of the linear DNA vaccine candidate.
Rationale for COVID-19 Linear DNA Vaccine Candidate for
Veterinary Use
In an article titled ‘Susceptibility of ferrets, cats, dogs, and
other domesticated animals to SARS-coronavirus 2’ published in
Science Magazine on May 29, 2020, the authors of the article
conducted research that found that “in cats the virus replicated in
the nose and throat and caused inflammatory pathology deeper in the
respiratory tract, and airborne transmission did occur between
pairs of cats”1. According to the CDC, roughly 60% of human
infectious diseases are zoonotic, such as rabies, Lyme disease,
West Nile virus, and MERS, among others. Globally and in the United
States, COVID-19 positive cats have been reported in small numbers.
The World Organization for Animal Health (OIE) indicates that
“infection of animals with COVID-19 virus meets the criteria of an
emerging disease2.”
Applied DNA’s LineaDNA vaccine candidates for COVID-19 have
previously demonstrated evidence of production of antibody and
T-cell responses at low doses of linear DNA in preclinical mouse
models. The Company believes that linear DNA vaccines have inherent
advantages over conventional DNA and RNA vaccines: they contain
only the desired therapeutic DNA sequence with reduced risk of
antibiotic resistance and genomic integration; they hold the
advantages of speed and scalability when manufactured by the
Company’s LinearDNA manufacturing platform; they are manufactured
at high levels of purity and with very simple means of production;
they are much more stable during storage and shipments than
RNA-based vaccines which is a practical advantage during a
worldwide deployment.
Dr. James A. Hayward, president and CEO of Applied DNA, stated,
“Animal health offers an efficient regulatory path with the U.S
Department of Agriculture that serves as a second avenue through
which to potentially commercialize our linear DNA COVID-19 vaccine
development work while having the ancillary benefit of progressing
our human related preclinical development work with the data
generated from this domestic cat study. Because animals and people
can both be affected by this zoonotic virus, and with much of the
world’s COVID-19 efforts centered on humans with very little known
about its effects on our closest companions with whom we share our
homes, we believe it prudent to pursue this avenue for the
therapeutic benefit of animals and humans alike.
“The collaboration between Applied DNA and Takis/Evvivax is a
natural outgrowth of cooperation between the companies that has its
roots in the field of cancer research with the development of a
linear DNA telomerase (anti-cancer) vaccine that was progressed to
COVID-19 vaccine development work. We now seek to apply the same
linear DNA vaccine candidates, whose results in small animal models
echo the effectiveness announced by some of the COVID-19 vaccines
already in human trials, to a veterinary vaccine candidate.”
Commenting on the collaboration, Dr. Luigi Aurisicchio, Chief
Executive and Scientific Officer of Takis Biotech and Evvivax,
said, “The holy grail would be to prevent COVID-19 as opposed to
waiting for it to start and then treating it. The implications of
success of this cat study would be quite large, both for cats and
people.”
1
https://science.sciencemag.org/content/sci/368/6494/1016.full.pdf
2
https://www.oie.int/en/scientific-expertise/specific-information-and-recommendations/questions-and-answers-on-2019novel-coronavirus/
About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable
supply chain security, anti-counterfeiting and anti-theft
technology, product genotyping and pre-clinical nucleic acid-based
therapeutic drug candidates.
Visit adnas.com for more information. Follow us on Twitter and
LinkedIn. Join our mailing list.
The Company’s common stock is listed on NASDAQ under ticker
symbol ‘APDN’, and its publicly traded warrants are listed on OTC
under ticker symbol ‘APPDW’.
Applied DNA is a member of the Russell Microcap® Index.
About Evvivax S.R.L.
Evvivax, whose name is derived from Engineered Veterinary
Vectored Immunotherapy and Vaccines, is a spin-off of Takis Biotech
(www.takisbiotech.it). Evvivax pursues the discovery and
development of innovative Therapeutic Veterinary Cancer Vaccines
based on proprietary viral vectors and DNA platform technologies.
Evvivax frontline candidates are two therapeutic cancer vaccines
for canine tumors: Tel-eVax and Erb-eVax. Evvivax aims at
translating scientific breakthrough achievements in Cancer
Immunotherapy into marketed innovative products in Veterinary and
subsequently in Human Oncology. More recently, Evvivax has moved to
developing innovative vaccines against zoonotic diseases, including
a vaccine against COVID-19 for pets. Evvivax is currently seeking
investors for further expanding the collaboration with ADNAS and
other Institutions.
Visit www.evvivax.com for more information.
Forward-Looking Statements
The statements made by Applied DNA in this press release may be
“forward-looking” in nature within the meaning of Section 27A of
the Securities Act of 1933, Section 21E of the Securities Exchange
Act of 1934 and the Private Securities Litigation Reform Act of
1995. Forward-looking statements describe Applied DNA’s future
plans, projections, strategies and expectations, and are based on
assumptions and involve a number of risks and uncertainties, many
of which are beyond the control of Applied DNA. Actual results
could differ materially from those projected due to the possibility
of a failure to make timely payment on its outstanding secured
convertible notes and resulting enforcement by noteholders of
remedies on collateral which includes substantially all of Applied
DNA’s assets, its history of net losses, limited financial
resources, limited market acceptance, the uncertainties inherent in
research and development, future clinical data and analysis,
including whether any of Applied DNA’s or its partners vaccine
candidates will advance further in the preclinical research or
clinical trial process, including receiving clearance from the U.S.
Food and Drug Administration (U.S. FDA), the U.S. Department of
Agriculture (USDA), or equivalent foreign regulatory agencies to
conduct clinical trials and whether and when, if at all, they will
receive final approval or licensure from the U.S. FDA, the USDA, or
equivalent foreign regulatory agencies, the unknown ability to
manufacture the vaccine candidates in large quantities, the fact
that the safety and efficacy of the vaccine candidates have not yet
been established, the unknown ability of the vaccine candidates to
generate revenue or profit for Applied DNA, the fact that there has
never been a commercial drug product utilizing PCR-produced DNA
technology approved for therapeutic use, the unknown outcome of any
applications or requests to U.S. FDA, USDA, or equivalent foreign
regulatory agencies, disruptions in the supply of raw materials and
supplies, and various other factors detailed from time to time in
Applied DNA’s SEC reports and filings, including our Annual Report
on Form 10-K filed on December 12, 2019 and our subsequent
quarterly reports on Form 10-Q filed on February 6, 2020, May 14,
2020 and August 6, 2020, and other reports we file with the SEC,
which are available at www.sec.gov. Applied DNA undertakes no
obligation to update publicly any forward-looking statements to
reflect new information, events or circumstances after the date
hereof or to reflect the occurrence of unanticipated events, unless
otherwise required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20200916005287/en/
Investor contact: Sanjay M. Hurry, Applied DNA Sciences,
917-733-5573, sanjay.hurry@adnas.com Program contact: Brian
Viscount, Applied DNA Sciences, 631-240-8877,
brian.viscount@adnas.com Web: www.adnas.com Twitter:
@APDN
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